Lacrima VR for Dry Eye Disease and Meibomian Gland Dysfunction

Официальное название

A Randomized, Masked (Evaluator), Sham-Controlled, Prospective Study to Evaluate the Safety and Effectiveness of the Lacrima VR System in Subjects With Dry Eye Disease and Meibomian Gland Dysfunction

Обзор

This is a prospective, multi-center, randomized, sham-controlled clinical investigation designed to evaluate the safety and effectiveness of the Lacrima VR system in adult subjects with Dry Eye Disease (DED) and Meibomian Gland Dysfunction (MGD). Subjects will be randomized in a 1:1 ratio to receive either active Lacrima VR treatment or a sham device with reduced luminance. Effectiveness will be assessed primarily by change in Tear Break-Up Time (TBUT), and safety will be evaluated by the incidence of device-related adverse events.

Подробное описание

Dry Eye Disease (DED) and Meibomian Gland Dysfunction (MGD) are common ocular surface disorders associated with tear film instability, ocular discomfort, and impaired visual function. The Lacrima VR system is a non-invasive medical device that delivers controlled sequences of light pulses using virtual reality technology, intended to activate reflex pathways associated with lacrimal and meibomian gland function.

This randomized, evaluator-masked study compares the Lacrima VR system with a sham device that is identical in appearance but operates at substantially reduced luminance. Subjects will undergo four treatment sessions at two-week intervals, followed by follow-up visits at 4 and 10 weeks after the final treatment. Effectiveness will be assessed using objective measures (TBUT) and patient-reported outcomes (OSDI). Safety assessments will include monitoring of adverse events, intraocular pressure, visual acuity, and discomfort questionnaires.

Вмешательства

• Устройство Lacrima VR System
  This is a prospective, randomized, sham-controlled, evaluator-masked clinical investigation designed to evaluate the safety and effectiveness of the Lacrima VR system in adult subjects with Dry Eye Disease (DED) and Meibomian Gland Dysfunction (MGD). Eligible participants will be randomized in a 1:1 ratio to receive either active Lacrima VR treatment or a sham device with reduced luminance. The intervention consists of four non-invasive treatment sessions administered at two-week intervals using

Первичные конечные точки

• Change From Baseline in Tear Break-Up Time (TBUT) at 4 Weeks [Срок оценки: Baseline to 4 weeks after final treatment]

Вторичные конечные точки (5)

• Change From Baseline in Tear Break-Up Time (TBUT) at 10 Weeks [Срок оценки: Baseline to 10 weeks after final treatment]
• Change From Baseline in Ocular Surface Disease Index (OSDI) [Срок оценки: Baseline to 4 weeks and 10 weeks after final treatment]
• Incidence of Device-Related Adverse Events [Срок оценки: Adverse events will be assessed from baseline (first treatment) and 10 weeks (±7 days) after their final treatment]
• Changes in Intraocular Pressure (IOP) [Срок оценки: Baseline to 4 and 10 weeks after final treatment]
• Changes in Best Corrected Visual Acuity (BCVA) [Срок оценки: Baseline to 4 and 10 weeks after final treatment]

Критерии участия

Критерии включения

• Adults aged 18 years and older
• Ability to provide written informed consent
• Willingness and ability to comply with study procedures and visits
• Self-reported dry eye symptoms for at least 3 months
• OSDI score ≥ 23 at baseline
• Tear Break-Up Time (TBUT) < 10 seconds in both eyes

Критерии исключения

• Ocular surgery within 1 year prior to screening
• Active ocular infection or inflammation
• History of ocular herpes infection within the past 3 months
• Use of contact lenses within 3 months prior to screening or during the study
• Use of prohibited dry eye or MGD treatments within protocol-defined washout periods
• Diagnosis of epilepsy
• Intraocular pressure > 20 mmHg
• Pregnancy or breastfeeding

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07415330 · CLN 0154

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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